Trial Information

Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

Treatment of hepatitis C with interferon and ribavirin has a virological effect. Viral
hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing
cirrhosis or hepatic cancer. In vitro studies of prazosin suggest an effect against hepatic
fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C
infection is unknown. The purpose of this multicentric national study is to compare the
effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or
not (placebo). 112 patients with a viral hepatitis C, genotype 1 or 4, and severe fibrosis,
will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and
ribavirin, with prazosin or with placebo. Peg-interferon alpha 2b will be administered once
a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according
to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks.
Evaluation will be done at 96 weeks. The primary end-point is the proportion of patients
presenting a decrease of fibrosis. Secondary end-points are other criteria of histological
response, virological response, biochemical response.